Enteral diet

ABSTRACT

A composition comprising arginine enriched whey protein can be used in the formulation of a variety of simulated food products to provide a substantially fat free, calorie controlled diet which delivers high levels of protein having a hypocholesterolemic amino acid profile.

This invention relates to the development of substantially fat free, controlled calorie enteral diet which delivers protein having a hypocholesterolemic amino acid profile when digested and absorbed.

BACKGROUND OF THE INVENTION

It has been reported in the literature that the reduction of elevated plasma cholesterol will decrease the risk of myocardial infarction secondary to atherosclerotic coronary heart disease in humans. It has been documented that plasma cholesterol levels decline to low levels in patients who are maintained on a total parenteral nutrition (TPN) program for extended periods of time. In such a program, all of the nutritional requirements are provided by the intravenous infusion of a solution containing a desired combination of amino acids, essential vitamins, minerals and trace elements, as well as dextrose for non protein caloric requirements.

Infusion of a modified fat free TPN amino acid formulation, Atheromine™, has been reported to induce a significant reduction in plasma cholesterol levels accompanied by regression of atherosclerosis in both animals and humans. "Regression of Atherosclerosis by the Intravenous Infusion of Specific Biochemical Nutrient Substrates in Animals and Humans", Dudrick, S. J., Annals of Surgery, Vol. 206, No. 3, pages 296-315 (1987), the disclosure of which is incorporated herein by reference. Atheromine™ amino acid formulation is disclosed in U.S. patent application Ser. No. 287,620, filed Dec. 16, 1988 for Method and Substrate Composition for Treating Atherosclerosis, the disclosure of which is herein incorporated by reference. In that study correlations between plasma amino acids and plasma cholesterol levels were demonstrated using a totally intravenous fat free diet containing 18 L-amino acids formulated in quantities and ratios deemed optimal for reducing plasma cholesterol levels in each patient. A number of amino acids, namely arginine, phenylalanine, isoleucine, valine, serine, aspartic acid and leucine were found to have a very strong inverse correlation between plasma amino acids and plasma cholesterol levels. However, in that study the reduction in plasma cholesterol levels and regression of atherosclerosis were limited to the direct intravenous infusion of the Atheromine™ amino acid solution. Oral administration of the amino acid composition was found to be ineffective in animals and humans in reducing plasma cholesterol or inducing regression of atherosclerosis.

SUMMARY OF THE INVENTION

The present invention is directed to oral and enteral dietary formulations which are substantially fat free and which deliver protein having a hypocholesterolemic amino acid profile when digested and absorbed, and to a composition for use in preparing such dietary formulations. As used herein, the term "substantially fat free" means a diet which provides less than 2 grams fat per day, with less than 1% of total calories as fat. The dietary formulations of the invention are based on the combination of L-arginine and whey protein, such as whey protein isolate having a protein content of at least 95% (N×6.38) (dry basis), to provide a composition useful in preparing a number of enteral food products which have an amino acid profile comparable to Atheromine™.

In addition to whey protein isolate and L-arginine, the composition may contain ingredients such as maltodextrin and starch, as well as one or more gums, thickening agents, flavors, and the like to provide desired caloric, nutritional and/or functional requirements. The whey protein in the composition preferably is produced by ion exchange from an aqueous whey source to provide whey protein isolate having a protein content of more than 95% and containing less than 1% of fat and lactose. The use of this high purity whey protein isolate not only provides superior nutritional values, but a variety of functional properties as well, such as foaming, gelling, water binding, fat binding and emulsifying, making the isolate a highly versatile ingredient. The arginine enriched whey protein composition can be used in preparing a wide variety of substantially fat free, controlled calorie food products having the desired amino acid profile, with the food products thus prepared being used in an extended enteral diet which delivers protein having a hypocholesterolemic amino acid profile when digested and absorbed. For example, the arginine enhanced whey protein isolate may be used to prepare both solid and liquid foods such as crepes, pasta, pasta sauce, pancakes, soups, french toast, banana loaf, mushroom omelet, and the like which are substantially fat free and have a controlled calorie level.

During digestion, proteins are hydrolysed to their constituent amino acids which are absorbed in the blood stream. Since the arginine enhanced whey protein composition and the enteral foods prepared with the composition have an amino acid profile comparable to the Atheromine™ TPN solution used in the Dudrick study discussed above, it appears that the enteral foods will, when digested and absorbed, deliver into the blood stream an amino acid profile having hypocholesterolemic properties. Accordingly, it is believed that humans having an elevated total plasma cholesterol will exhibit a significant reduction in total plasma cholesterol and regression of atherosclerosis when maintained on the enteral diet of the present invention.

DETAILED DESCRIPTION

In accordance with the present invention, enteral foods having a desired amino acid profile and nutritional requirements and which are suitable for use in preparing a substantially fat free enteral diet having a hypocholesterolemic amino acid profile are provided through the use of a composition of containing L-arginine and whey protein such as whey protein isolate which contains on a dry basis at least 95% protein (N×6.38) and less than 1% fat and lactose. The low levels of fat and lactose provide the whey protein with superior functionality and nutrition, enabling it to be used in a variety of enteral nutritional compositions. A preferred source of high purity whey protein is BiPRO®, available from Le Sueur Isolates, Le Sueur, Minn. BiPRO®, which is produced by the hydrophilic ion exchange treatment of whey, contains over 95% protein (dry basis), less than 3% mineral salts, and less than 1% fat and lactose, with the protein being undenatured and therefore fully soluble. The use of BiPRO® is advantageous in the present invention for it not only provides superior nutritional values, but its functional properties such as foaming, gelling, and emulsifying make it highly versatile. For example BiPRO® forms a tough but elastic gel upon heating, enabling a variety of products to be formulated from the arginine enriched BiPRO® composition.

Whey protein isolate is enriched with sufficient L-arginine to provide a composition having excellent nutritional values and an amino acid profile comparable to the Atheromino™ parenteral solution disclosed in U.S. patent application Ser. No. 287,620 entitled: "METHOD AND SUBSTRATE COMPOSITION FOR TREATING ATHEROSCLEROSIS," filed on Dec. 16, 1988 referred to hereinabove which was successfully used in the Dudrick study to reduce plasma cholesterol levels. Table 1 below sets out an amino acid profile comparison of the protein content of the Atheromine™ parenteral solutions tested, BiPRO® whey protein isolate, and an arginine enriched whey protein composition of this invention obtained by adding 0.16 parts by weight of L-arginine per part by weight of BiPRO® whey protein isolate.

                  TABLE 1                                                          ______________________________________                                         AMINO ACID PROFILE COMPARISON                                                  (Percent by Weight)                                                            Amino                            ARG-enriched                                  Acid       Atheromine™                                                                             BiPRO ®                                                                              BiPRO ®                                   ______________________________________                                         Isoleucine  4.0-10.0   4.77      4.09                                          Leucine     5.0-10.0   12.44     10.67                                         Lysine     4.5-6.5     9.35      8.02                                          Methionine 3.5-6.5     4.21      3.61                                          & Cysteine                                                                     Phenylalanine                                                                             4.5-8.5     6.64      5.70                                          & Tyrosine                                                                     Threonine  2.0-3.5     4.40      3.71                                          Tryptophane                                                                               1.0-2.5     1.78      1.52                                          Valine     4.0-9.0     4.49      3.85                                          Alanine     7.0-16.0   4.49      3.85                                          Arginine    9.0-18.0   2.62      16.49                                         Histidine  1.5-3.5     9.35      8.02                                          Proline    4.5-8.5     4.30      3.69                                          Serine     2.5-6.5     4.49      3.85                                          Glycine    3.0-8.0     1.50      1.28                                          Glutamic Acid                                                                             3.5-5.5     14.97     12.83                                         Aspartic Acid                                                                             2.0-4.0     10.20     8.74                                                                 100.00    100.00                                        ______________________________________                                    

The arginine enriched whey protein composition is substantially fat free and, due to the superior functionality of the high purity, whey protein, may be formulated into a wide variety of enteral foods to provide a substantially fat free, controlled calorie diet delivering high levels of protein with a hypocholesterolemic amino acid profile.

Preferably the whey protein isolate and arginine are combined with one or more additional ingredients which provide the composition with a desired level of nutrition or with certain functional characteristics. For example, maltodextrin and/or starch may be included for non-protein caloric requirements. One or more non-nutritive materials may also be included for controlling the texture of foods formulated from the composition, such as hydrocolloids, polysaccharides, and the like to function as a thickener, gelling agent, etc. in the composition.

A suitable formulation for preparing foods used in a substantially fat free, controlled calorie diet which delivers a high level of protein having a hypocholesterolemic amino acid profile is set out in Table 2. the formulation is prepared by mixing the ingredients, in the amounts indicated, in 100 ml water.

                  TABLE 2                                                          ______________________________________                                                    Amount   Protein  CHO   Fat                                         Ingredient (gm)     (gm)     (gm)  (gm)  Kcal                                  ______________________________________                                         BiPRO® whey                                                                           13.77    13.00    0.01  0.00  52.08                                 protein                                                                        isolate                                                                        Starch     10.00             9.50        38.00                                 Maltodextrin,                                                                             6.50              6.18        24.70                                 DE4                                                                            L-Arginine 2.16     2.12                 8.47                                  Flavor     0.20                          0.00                                  Xanthan gum                                                                               0.10                          0.00                                  Carrageenan                                                                               0.10                          0.00                                  TOTAL      32.83    15.12    15.69 0.00  123.24                                ______________________________________                                    

The arginine enriched whey protein composition, either in the form of a dry mix or as an aqueous composition may be used to prepare a wide variety of simulated food products for use in a calorie controlled, substantially fat free enteral diet. Set out in Table 3 below is a representative seven day rotational diet based on the arginine enriched whey protein isolate composition, which is formulated to provide a 70 kg person approximately 1800 Kilocalories and no more than 2 gms of fat per day while delivering a high level of protein having a hypocholesterolemic amino acid profile.

                  TABLE 3                                                          ______________________________________                                         Menu #1 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Banana Pancakes                                                                            100    g       2 Protein Powder                                                                          0.1                                      Unsweetened 8      oz      2 Fruit    0.2                                      Orange Juice                                                                   Canned Pear 2      halves  1 Fruit    0.1                                      Halves - Juice Pack                                                            (no sugar added)                                                               Syrup       1      Tbsp    Free       0.0                                      Sugar-Free Syrup                                                                           1      Tbsp    Free       0.0                                      SNACK                                                                          Breadsticks 150    g       3 Protein Powder                                                                          0.15                                     Canned Fruit                                                                               1      cup     2 Fruit    0.0                                      Cocktail                                                                       LUNCH                                                                          Beef Stir-Fry                                                                              100    g       2 Protein Powder                                                                          0.1                                      Onion,                     2 Vegetable                                                                               0.375                                    Frozen Veggies                                                                 Canned Peaches -                                                                           4      halves  2 Fruit    0.0                                      Juice Pack                                                                     (no sugar added)                                                               Rice Cakes  2      cakes   1 Grain    0.0                                      Diet Beverage                                                                              8      oz                 0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          "French Fries"                                                                             150    g       3 Protein Powder                                                                          0.15                                     Canned Cherries                                                                            1/2    c       1 Fruit    0.0                                      (no sugar added)                                                               DINNER                                                                         Vegetarian Pizza                                                                           100    g       2 Protein Powder                                                                          0.1                                      Fresh Green Pep-           1 Vegetable                                                                               0.3                                      per, Mushrooms,                                                                Onion                                                                          Frozen Broccoli,                                                                           1/4    cup     1/2 Vegetable                                                                             0.1                                      steamed                                                                        Unsweetened 1      cup     2 Fruit    0.0                                      Pineapple                                                                      SNACK                                                                          Corn Bread  150    g       3 Protein Powder                                                                          0.15                                     Unsweetened 1/3    cup     1 Fruit    0.1                                      Grape Juice                                                                    with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                               TOTAL GRAMS OF FAT:                                                                               1.925                                                       TOTAL FAT EXCHANGES:                                                                              191/4                                                       TOTAL KILOCALORIES:                                                                               1806                                                        TOTAL GRAMS OF PROTEIN:                                                                           120.3                                              Reference to Protein Powder is to the use of the arginine                      enriched whey protein of the present invention which is                        used to create the entree that includes protein. Pursuant                      to the present invention, this provides the substantially                      fat free Enteral Diet. Examples of recipes for creating                        the entree using the protein powder are set forth after                        the seven day diet.                                                            ______________________________________                                         Menu #2 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Cinnamon    150    g       3 Protein Powder                                                                          0.15                                     Applesauce Cake                                                                Unsweetened 1/4    cup     1/2 Fruit  0.05                                     Applesauce                                                                     Unsweetened 1/2    cup     1 Fruit    0.0                                      Pineapple                                                                      Juice with  10     g       1 Starch Powder                                                                           0.0                                      Starch Powder                                                                  LUNCH                                                                          Potato      100    g       2 Protein Powder                                                                          0.1                                      Asparagus Soup                                                                 Canned Asparagus,          11/2 Vegetable                                                                            0.4                                      Onion                                                                          Wheat Cakes 4      cakes   2 Grain    0.0                                      Peach Nectar                                                                               2/3    cup     2 Fruit    0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Popsnacks   200    g       4 Protein Powder                                                                          0.2                                      Cranberry Juice                                                                            1/3    c       1 Fruit    0.1                                      DINNER                                                                         Pasta       150    g       3 Protein Powder                                                                          0.15                                     Tomato Sauce                                                                               1/2    cup     1 Vegetable                                                                               0.15                                     (NO OIL)                                                                       Fresh Zucchini,                                                                            1      cup     1 Vegetable                                                                               0.1                                      cooked                                                                         Wasa Crisp Bread                                                                           11/2   slices  1 Grain    0.0                                      (Hearty Rye)                                                                   Unsweetened 1      cup     2 Fruit    0.2                                      Orange Juice                                                                   with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Crepes      150    g       3 Protein Powder                                                                          0.15                                     Boysenberry Sauce                                                                          1/2    cup     1 Fruit    0.15                                     with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                               TOTAL GRAMS OF FAT:                                                                               1.90                                                        TOTAL FAT EXCHANGES:                                                                              19                                                          TOTAL KILOCALORIES:                                                                               1804                                                        TOTAL GRAMS OF PROTEIN:                                                                           129.2                                              ______________________________________                                         Menu #3 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Scrambled Eggs                                                                             100    g       2 Protein Powder                                                                          0.1                                      with Vegetables            1 Vegetable                                                                               0.14                                     Fresh Onion,                                                                   Green Pepper                                                                   Unsweetened 1/2    cup     1 Fruit    0.1                                      Grapefruit                                                                     Juice with  10     g       1 Starch Powder                                                                           0.0                                      Starch Powder                                                                  SNACK                                                                          Carrot Sponge Cake                                                                         100    g       2 Protein Powder                                                                          0.1                                      Shredded Carrots,                                                                          1/2    cup     1 Vegetable                                                                               0.1                                      raw                                                                            Lemonade, frozen                                                                           12/3   cup     21/2 Fruit 0.0                                      concentrate with                                                               Starch Powder                                                                              10     g       1 Starch Powder                                                                           0.0                                      LUNCH                                                                          Croutons    100    g       2 Protein Powder                                                                          0.1                                      Iceberg Lettuce                                                                            21/2   leaves  1/4 Vegetable                                                                             0.1                                      Boiled Red Beets                                                                           1      cup     2 Vegetable                                                                               0.0                                      Tasti-Diet  1      Tbsp    Free       0.0                                      Dressing                                                                       (oil and sugar-                                                                free)                                                                          Canned Mandarin                                                                            1/4    cup     1/2 Fruit  0.05                                     Orange                                                                         SNACK                                                                          Crunchy Carrots                                                                            11/2   cup     3 Vegetable                                                                               0.3                                      (raw)                                                                          with Bacon  150    g       3 Protein Powder                                                                          0.15                                     Unsweetened 1/2    cup     1 Fruit    0.1                                      Apple Juice                                                                    with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      DINNER                                                                         Spoon Burger                                                                               100    g       2 Protein Powder                                                                          0.1                                      Veggies in Recipe          1 Vegetable                                                                               0.169                                    San Rice    4      cakes   2 Grain    0.0                                      Cakes                                                                          Apricot Nectar                                                                             1/2    cups    1 Fruit    0.1                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Pumpkin Pie 100    g       2 Protein Powder                                                                          0.1                                      Squares                                                                        Canned Pumpkin                                                                             1/4    cup     1 Vegetable                                                                               0.17                                     Unsweetened 1      cup     2 Fruit    0.0                                      Pineapple Juice                                                                with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                               TOTAL GRAMS OF FAT:                                                                               1.98                                                        TOTAL FAT EXCHANGES:                                                                              193/4                                                       TOTAL KILOCALORIES:                                                                               1797                                                        TOTAL GRAMS OF PROTEIN:                                                                           122.7                                              ______________________________________                                         Menu #4 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      French Toast                                                                               150    g       3 Protein Powder                                                                          0.15                                     *Syrup      2      Tbsp    Free       0.0                                      **Sugar-Free Syrup                                                                         3      Tbsp    Free       0.0                                      Figs        2      Figs    1/2 Fruit  0.1                                      Diet Beverage                                                                              1      cup     Free       0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Kellogg's   1      cup     11/4 Grain 0.0                                      Product 19                                                                     Peach Nectar                                                                               1      cup     3 Fruit    0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      LUNCH                                                                          Polynesian Chicken                                                                         200    g       4 Protein Powder                                                                          0.2                                      Snap Green Beans,                                                                          1      cup     1 Vegetable                                                                               0.1                                      canned                                                                         Grapefruit, raw                                                                            1      half    1/2 Fruit  0.1                                      Diet Beverage                                                                              1      cup     Free       0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Onion Squares                                                                              100    g       2 Protein Powder                                                                          0.1                                      Fresh Onions                                                                               1/4    cup     1/2 Vegetable                                                                             0.1                                      Fresh Cucumbers                                                                            2      cups    1 Vegetable                                                                               0.2                                      Tasti-Diet Dressing                                                                        1      Tbsp    Free       0.0                                      (oil and sugar-free)                                                           Unsweetened 1/2    cup     1 Fruit    0.1                                      Apple Juice                                                                    with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      DINNER                                                                         Broccoli    100    g       2 Protein Powder                                                                          0.1                                      Tomato Quiche                                                                  Fresh Onion,               13/4 Vegetable                                                                            0.35                                     Tomato, Broccoli                                                               Boiled Zucchini                                                                            1      cup     1 Vegetable                                                                               0.1                                      Squash                                                                         Canned Peach                                                                               4      halves  2 Fruit    0.0                                      Halves Juice Pack                                                              (no sugar added)                                                               Diet Beverage                                                                              1      cup     Free       0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Tangy Orange Bars                                                                          200    g       4 Protein Powder                                                                          0.2                                      Unsweetened 1/2    cup     1 Fruit    0.1                                      Orange Juice                                                                   with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                               TOTAL GRAMS OF FAT:                                                                               2.0                                                         TOTAL FAT EXCHANGES:                                                                              20                                                          TOTAL KILOCALORIES:                                                                               1805                                                        TOTAL GRAMS OF PROTEIN:                                                                           128.3                                              ______________________________________                                         Menu #5 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Cinnamon    150    g       3 Protein Powder                                                                          0.15                                     Applesauce Cake                                                                Unsweetened 1/4    cup     1/2 Fruit  0.0                                      Applesauce                                                                     Canned      1/2    cup     1 Fruit    0.0                                      Fruit Cocktail                                                                 Juice Pack                                                                     (no sugar added)                                                               with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      LUNCH                                                                          Shrimp Stuffed                                                                             50     g       1 Protein Powder                                                                          0.05                                     Tomato                                                                         Fresh Tomato                                                                               1      large   1 Vegetable                                                                               0.3                                      Fresh Onion,                                                                               1/8    cup     1/4 Vegetable                                                                             0.1                                      Green Pepper                                                                   "Mashed Potatoes"                                                                          100    g       2 Protein Powder                                                                          0.1                                      Unsweetened 1      cup     2 Fruit    0.2                                      Apple Juice                                                                    SNACK                                                                          Green Beans 100    g       2 Protein Powder                                                                          0.1                                      With Ham                                                                       Canned Green               11/2 Vegetable                                                                            0.07                                     Beans, Water Chest-                                                            nuts, & Raw Celery                                                             Sesame Cakes                                                                               2      cakes   1 Grain    0.0                                      DINNER                                                                         Chicken Loaf                                                                               200    g       4 Protein Powder                                                                          0.2                                      Long Grain White                                                                           1/3    cup     1 Grain    0.0                                      Rice, cooked                                                                   Unsweetened 1/2    cup     1 Fruit    0.1                                      Applesauce                                                                     Unsweetened 1      cup     3 Fruit    0.3                                      Grape Juice                                                                    with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Canned Peaches -                                                                           4      halves  2 Fruit    0.0                                      Juice Pack                                                                     (no sugar added)                                                               Breadsticks 150    g       3 Protein Powder                                                                          0.15                                              TOTAL GRAMS OF FAT:                                                                               1.87                                                        TOTAL FAT EXCHANGES:                                                                              183/4                                                       TOTAL KILOCALORIES:                                                                               1801                                                        TOTAL GRAMS OF PROTEIN:                                                                           124.7                                              ______________________________________                                         Menu #6 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Cinnamon    100    g       2 Protein Powder                                                                          0.1                                      Raisin Bread                                                                   Raisins     2      Tbsp    1 Fruit    0.06                                     Lemonade, frozen                                                                           2/3    cup     1 Fruit    0.0                                      SNACK                                                                          Corn-Flavored                                                                              150    g       3 Protein Powder                                                                          0.15                                     Pop Snack                                                                      Peach Nectar                                                                               1/3    cup     1 Fruit    0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      LUNCH                                                                          Pineapple Spinach                                                                          100    g       2 Protein Powder                                                                          0.1                                      Chicken                                                                        Canned Pineapple                                                                           1/3    cup     1 Fruit    0.1                                      Chunks Juice Pack                                                              (no sugar added)                                                               Frozen, chopped                                                                            1      cup     2 Vegetable                                                                               0.4                                      Spinach                                                                        Sesame Cakes                                                                               3      cakes   11/2 Grain 0.0                                      Canned Fruit                                                                               1      cup     2 Fruit    0.0                                      Cocktail Juice Pack                                                            (no sugar added)                                                               with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Mashed Potatoes                                                                            150    g       3 Protein Powder                                                                          0.15                                     Diet Beverage                                                                              1      cup     Free       0.0                                      with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      DINNER                                                                         Hungarian Cabbage                                                                          100    g       2 Protein Powder                                                                          0.1                                      Rolls                                                                          Fresh Onions                                                                               1/4    cup     1/2 Vegetable                                                                             0.1                                      Fresh Mushrooms                                                                            1/4    cup     1/2 Vegetable                                                                             0.16                                     Cabbage Leaves                                                                             2      leaves  1 Vegetable                                                                               0.13                                     Tomato Juice                                                                               1/3    cup                0.09                                     and Sauce                                                                      White Long  1/3    cup     1 Grain    0.0                                      Grain Rice,                                                                    cooked                                                                         Unsweetened 1/2    cup     1 Fruit    0.1                                      Grapefruit Juice                                                               with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      SNACK                                                                          Breadsticks 150    g       3 Protein Powder                                                                          0.15                                     Apricot Nectar                                                                             1/2    cup     1 Fruit    0.1                                               TOTAL GRAMS OF FAT:                                                                               1.99                                                        TOTAL FAT EXCHANGES:                                                                              193/4                                                       TOTAL KILOCALORIES:                                                                               1806                                                        TOTAL GRAMS OF PROTEIN:                                                                           129.1                                              ______________________________________                                         Menu #7 - 1800 Calories                                                                                            FAT                                        MEAL        AMOUNT     EXCHANGE     GRAMS                                      ______________________________________                                         BREAKFAST                                                                      Crepes - 4  200    g       4 Protein Powder                                                                          0.2                                      Peach Nectar                                                                               1/3    cup     1 Fruit    0.0                                      Sauce with                                                                     Canned Peaches                                                                             4      halves  2 Fruit    0.0                                      (no sugar added)                                                               and Starch Powder                                                                          10     g       1 Starch Powder                                                                           0.0                                      Kellogg's   3/4    cup     1 Grain    0.0                                      Special K                                                                      LUNCH                                                                          Apple-Vegetable                                                                            100    g       2 Protein Powder                                                                          0.1                                      Scramble                                                                       Fresh Apple,                                                                               1/2    apple   1/2 Fruit  0.15                                     chopped                                                                        Fresh Celery,                                                                              1      stalk   1/2 Vegetable                                                                             0.1                                      chopped                                                                        Fresh Onion,                                                                               1/4    cup     1/2 Vegetable                                                                             0.1                                      chopped                                                                        Fresh Carrot,                                                                              1/2    cup     1 Vegetable                                                                               0.1                                      chopped                                                                        Wheat Cakes 4      cakes   2 Grain    0.0                                      SNACK                                                                          Banana Loaf 150    g       3 Protein Powder                                                                          0.15                                     Lemonade, frozen                                                                           2/3    cup     1 Fruit    0.0                                      concentrate, pre-                                                              pared                                                                          with Starch Powder                                                                         10     g       1 Starch Powder                                                                           0.0                                      DINNER                                                                         Zucchini Omelet                                                                            50     g       1 Protein Powder                                                                          0.05                                     Fresh Zucchini                                                                             1/2    large   1 Vegetable                                                                               0.1                                      Squash                                                                         "French Fries"                                                                             100    g       2 Protein Powder                                                                          0.1                                      Canned Pear Halves                                                                         4      halves  2 Fruit    0.2                                      Juice Pack                                                                     (no sugar added)                                                               SNACK                                                                          Corn Bread  150    g       3 Protein Powder                                                                          0.15                                     Canned Pineapple                                                                           2/3    cup     2 Fruit    0.2                                      Chunks Juice Pack                                                              (no sugar added)                                                                        TOTAL GRAMS OF FAT:                                                                               1.70                                                        TOTAL FAT EXCHANGES:                                                                              17                                                          TOTAL KILOCALORIES:                                                                               1803                                                        TOTAL GRAMS OF PROTEIN:                                                                           128.3                                              ______________________________________                                         Representative recipes that were used to prepare the                           protein products are as follows:                                               ______________________________________                                         Batter I (Basic Preparation)                                                   Exchange: 8 Protein Powder (composition of Table 2)                            Recipe:                                                                        Protein Powder                                                                               132 grams                                                        Water         270 grams                                                        Instructions:                                                                  Mix the dry Protein Powder and water in a mixing bowl                          until all dry powder is moistened. Transfer the wet                            mixture to a blender. Blend for 1 minute at high speed.                        Stop the blender, scrape the sides, and gently stir the                        batter. Blend for an additional 1 minute. A fresh batch                        of batter should be prepared each day and refrigerated                         covered with saran wrap when stored for the day.                               Most of the recipes use this batter consistency.                               Table to determine amount of batter needed for the day:                        Exchanges:      8      10     12   14   16                                     Protein Powder (grams)                                                                         132    165    198  231  264                                    Water (grams)   270    337    404  471  538                                    Batter II (Basic Preparation)                                                  Exchange: 8 Protein Powder (composition of Table 4)                            Recipe:                                                                        Protein Powder                                                                               132 grams                                                        Water         348 grams                                                        Instructions:                                                                  Mix the dry Protein Powder and water in a mixing bowl                          until all dry powder is moistened. Transfer the wet                            mixture to a blender. Blend for 1 minute at high speed.                        Stop the blender, scrape the sides, and gently stir the                        batter. Blend for an additional 1 minute. A fresh batch                        of batter should be prepared each day and refrigerated                         covered with saran wrap when stored for the day.                               Recipes that use this batter consistency include:                              Onion Squares                                                                  Banana Loaf                                                                    Cinnamon raisin bread                                                          Corn bread                                                                     Mashed potatoes                                                                Crepes                                                                         French toast                                                                   Pancakes                                                                       Carrot sponge cake                                                             Pumpkin pie squares                                                            Table to determine amount of batter needed for the day:                        Exchanges:      2      4      6    8    10                                     Protein Powder (grams)                                                                         33     66     99   132  165                                    Water (grams)   87     174    261  348  435                                    Beef Stir-Fry                                                                  Exchange:     2 Protein Powder                                                               2 Vegetable                                                      Recipe:                                                                        Batter I               100    grams                                            Rich Brown Seasoning   1      packet                                           Onions, chopped        1/8    cup                                              Frozen Vegetables (thawed)                                                                            1      cup                                              (carrots, zucchini, broccoli, cauliflower)                                     Instructions:                                                                  Mix Rich Brown Seasoning with Batter I. Pour into a small                      microwave container and cover tightly with lid (snap                           seal). Cook on the Defrost cycle for 31/2 minutes. Cut                         into small (1/4") cubes.                                                       Place onions and thawed vegetables in a non-stick frying                       pan. Stir fry over medium heat on the stove until onions                       and vegetables are half cooked (not browned). DO NOT                           ADD ANY FAT OR SPRAY ON SUBSTANCE LIKE                                         PAM. Add the beef cubes and continue cooking until the                         diced cubes turn golden brown on the edges.                                    Yield: 1 Serving                                                               Pineapple Spinach Chicken                                                      Exchange:     2 Protein Powder                                                               2 Vegetable                                                                    1 Fruit                                                          Recipe:                                                                        Batter I          100       grams                                              Golden Seasoning  2         packets                                            Water             1/4       cup                                                Ginger, Ground    1/4       tsp                                                Equal           as desired (suggest 7 packets)                                 Frozen Chopped Spinach                                                                           1         cup                                                (thawed)                                                                       Pineapple chunks, Juice                                                                          1/3       cup                                                packed, (drained)                                                              Instructions:                                                                  Add one packet of golden seasoning to the Batter I and mix                     well. Pour into a small microwave container and cover                          tightly with a lid (snap seal). Cook on the Defrost cycle                      for 31/2 minutes. Cut into bite size pieces.                                   Place other packet of golden seasoning, water, Equal, and                      ginger in a sauce pan. Cook over medium heat, stirring                         occasionally until mixture comes to a boil. Add                                chicken-flavored pieces, spinach, and pineapple to the                         boiling mixture. Cover, reduce heat, and simmer for                            10 minutes.                                                                    Yield: 1 Serving                                                               French Fries                                                                   Exchange: 2 Protein Powder                                                     Recipe:                                                                        Batter I      100 grams                                                        Potato Flavor pinch (3 grams)                                                  Instructions:                                                                  Thoroughly mix Batter I and the potato flavor using a wire                     whisk or fork. Spread the mixture evenly into a small                          microwave container and cover tightly with a lid (snap                         seal) or plastic wrap. Cook on the Defrost cycle for                           2 minutes 30 seconds. Cool and place removed loaf on a                         dish. Cut the loaf width wise into 1/4 to 1/2 inch                             strips. Stir fry the strips in a non-stick frying pan                          until golden brown on all sides. DO NOT ADD FAT OR                             SPRAY ON SUBSTANCE LIKE PAM.                                                   Yield: 1 Serving                                                               Mashed Potatoes                                                                Exchange: 2 Protein Powder                                                     Recipe:                                                                        Batter II     100 grams                                                        Potato Flavor  3 grams                                                         Instructions:                                                                  Thoroughly mix Batter II and the potato flavor using a                         wire whisk or fork. Pour batter into a non-stick frying                        pan. DO NOT ADD FAT OR SPRAY ON SUBSTANCE                                      LIKE PAM. Cook over medium heat with constant stirring                         until desired texture (scrambled egg like) is achieved.                        ______________________________________                                          *non-diabetic                                                                  **diabetic                                                               

Thus, the arginine enriched whey protein isolate may be formulated into substantially fat free, controlled calorie enteral foods which deliver protein having a hypocholesterolemic amino acid profile when digested and absorbed.

It would appear that plasma cholesterol levels in humans can be significantly reduced and controlled, and coronary atherosclerosis arrested and reversed by maintaining such persons for an extended period, such as, for example, 3 weeks to 3 months, on a substantially fat free, controlled calorie diet, such as the seven day rotational diet disclosed above, utilizing the arginine enriched, whey protein isolate composition of this invention. 

What is claimed is:
 1. A composition for use in preparing substantially fat free enteral foods for use in the treatment of atherosclerosis which comprises whey protein and an amount of L-arginine sufficient to provide the composition with a hypocholesterolemic amino acid profile.
 2. The composition defined in claim 1 in which said whey protein is whey protein isolate containing at least 95% protein (dry basis) and less than 1% fat and lactose.
 3. The composition defined in claim 2 in which the arginine is present in an amount of about 0.16 parts by weight per part by weight of the whey protein isolate.
 4. An enteral diet for use in the treatment of hypercholesterolemia which comprises substantially fat free foods formulated from a mixture of whey protein and an amount of L-arginine to provide the mixture with a hypocholesterolemic amino acid profile.
 5. The enteral diet defined in claim 4 in which the diet provides less than 2 grams fat per day, with less than 1% of the calories being derived from fat.
 6. The enteral diet defined in claim 4 in which the whey protein is whey protein isolate containing at least 95% protein (dry basis) and less than 1% fat and lactose.
 7. A method of reducing plasma cholesterol in patients having elevated cholesterol levels which comprises maintaining the patients on a substantially fat free, high protein enteral diet in which the protein has a hypocholesterolemic acid profile provided by a mixture of whey protein and L-arginine for a period of time sufficient to reduce plasma cholesterol levels.
 8. The method defined in claim 7 in which the diet provides less than 2 grams of fat per day, with less than 1% of the calories being derived from fat.
 9. The method defined in claim 8 in which the whey protein is whey protein isolate containing over 95% protein (dry basis) and less than 1% fat and lactose, with the protein being substantially undenatured. 